Impact

Primary DI
00810135963374
Brand
Impact
Company
NVision Biomedical Technologies, Inc.
Model
PP-1001T-CUT3
Device description
PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.
Published
2025-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810135963374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135963374008101359633748101359633740810135963374

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent rigid or bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws, endodontic files/rasps). It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2105985938denisealva@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005663762ToejackTB-30-20L2026-07-29
00810005663779ToejackTB-30-22L2026-07-29
00810005665711ToejackTB-30-18L2026-07-29
00810005668828TrigonTB-30-18N2026-07-29
00810005668835ToeJackTB-30-20N2026-07-29
00810005668842ToejackTB-30-22N2026-07-29
00810135961196ToeJackTJB-30-302026-07-29
00810135961202ToejackTJB-1000T-D30S2026-07-29
00810135961219ToejackTJB-1000T-D30C2026-07-29
00810135961226ToejackTJB-1000T-T8CI2026-07-29
00810135961233ToejackTJB-1001T-DPG2026-07-29
00810135961257ToejackTJB-1001T-SG032026-07-29
00810135961288ToejackTJB-1000T-PKS2026-07-29
00810135961769ToejackTJB-30-14HL2026-07-29
00810135961776ToejackTJB-30-16HL2026-07-29
00810135961783ToejackTJB-30-18HL2026-07-29
00810135961790ToejackTJB-30-20HL2026-07-29
00810135961806ToejackTJB-30-22HL2026-07-29
00810135963121ToeJack Bunion Correction SystemTJB-1000C-1052026-07-29
00810135965088ToeJack Bunion Correction SystemTJB-1000C-1042026-07-29

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